DOTCOM Study

Study Name

Study Number

14-I-0009

Goal of Study

The National Institutes of Health (NIH) is conducting a research study for people whose HIV infection is not currently under control, despite taking HIV medications. In general, the medicine used to treat HIV infection called antiretroviral therapy (ART) can decrease the amount of HIV virus in your blood (also called viral load or HIV RNA) to a very low level. This only happens if the ART drugs used still work to fight off the HIV virus from your body, and if you are taking the ART drugs every day, as instructed by your primary care doctor. When ART drugs no longer work against the HIV virus, the virus is said to become “resistant” to the drugs. We are interested in learning more about how to control HIV infection in people who can’t get a lower viral load despite receiving ART drugs.

Study Regimen

A total of 100 subjects, 14 years of age or older, are expected to join the study. To be in the study, you must have a primary care doctor, and be willing to be hospitalized for the inpatient stays, have your blood samples stored, and undergo genetic testing. You are expected to be in the study for two years or longer, if necessary. After a screening visit and a baseline visit, you will need to stay at the NIH as an inpatient for seven to eight days to observe how you take your HIV medications. Blood levels will be drawn every other day. There will be follow-up visits to track your medication adherence and for physical exams and labs.

Eligibility Criteria

You are HIV-positive and age 14 or older.

You have had to change your HIV drug regimen in the past because your viral load was >1,000.

You have had a HIV viral load on your current regimen of >1,000 two consecutive times.

You are able to be admitted to the NIH for seven to eight days.

If female, you are not currently pregnant or breast feeding.

You live in the DC Metro area, and can travel to the NIH in Bethesda, Maryland.